ESD · Class I · 21 CFR 874.3300

FDA Product Code ESD: Hearing Aid, Air-conduction, Prescription

An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.

Leading manufacturers include Unitron Industries, Inc., Miracle-Ear, Inc. and Electone, Inc..

1367
Total
1367
Cleared
56d
Avg days
1976
Since
1367 devices
337–360 of 1367
Cleared Oct 13, 1993
HI BAND
K934452
Argosy Electronics
Ear, Nose, Throat · 33d
Cleared Oct 08, 1993
LINEAR PLUS
K934442
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 08, 1993
2:1 INPUT COMPRESSION
K934443
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 08, 1993
K-AMP
K934444
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 08, 1993
POWER MANHATTAN II
K934446
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 08, 1993
LINEAR PLUS-POWER
K934447
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 08, 1993
POWER 3-CHANNEL-CLOCK
K934448
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 08, 1993
3-CHANNEL K-AMP
K934449
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 08, 1993
MANHATTAN 3-CHANNEL
K934450
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 08, 1993
3-CHANNEL CLOCK
K934453
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 08, 1993
MANHATTAN II
K934454
Argosy Electronics
Ear, Nose, Throat · 28d
Cleared Oct 07, 1993
STARKEY TYMPANETTE HEARING AID
K933407
Starkey Laboratories, Inc.
Ear, Nose, Throat · 87d
Cleared Oct 07, 1993
BOSCH EUROSTAR
K933988
Starkey Laboratories, Inc.
Ear, Nose, Throat · 51d
Cleared Oct 07, 1993
RESOLUTION ITC HEARING AID
K933989
Starkey Laboratories, Inc.
Ear, Nose, Throat · 51d
Cleared Sep 18, 1993
AS-90
K923006
Qualitone
Ear, Nose, Throat · 453d
Cleared Sep 07, 1993
PHILIPS 45 SERIES
K933850
Philips Hearing Instruments Co.
Ear, Nose, Throat · 32d
Cleared Aug 23, 1993
MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID
K933291
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 48d
Cleared Aug 23, 1993
MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID
K933579
Telex Communications, Inc.
Ear, Nose, Throat · 31d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 12 (L12)
K933640
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 6 (L6)
K933643
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 8 (L8)
K933644
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 19, 1993
BELTONE PRIMA 2000
K932703
Beltone Electronics Corp.
Ear, Nose, Throat · 77d
Cleared Aug 05, 1993
OTICON MF
K932670
Oticon Corp.
Ear, Nose, Throat · 64d
Cleared Aug 02, 1993
GOLD ASP MODULE, ITE
K933036
Electone, Inc.
Ear, Nose, Throat · 96d